Transcription of Electronic submission of Article 57(2) data …
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Electronic submission of Article 57(2) data …
6 July 2017. EMA/159776/2013. Information Management Electronic submission of Article 57(2) data Questions & Answers (Q&As). Version 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website An agency of the European Union European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. Table of contents Summary of changes .. 8. 1. SCOPE OF Article 57(2) of Regulation (EC) No 726/2004 .. 9. Medicinal products within the scope of Article 57(2) .. 9. Medicinal products out of scope of Article 57(2) .. 9. submission of centrally authorised medicinal products (CAPs) .. 10. submission of Investigational Medicinal Products (IMPs) .. 10. submission of herbal medicinal products.
Electronic submission of Article 57(2) data EMA/159776/2013 Page 3/75 3.5. Submission of medicinal products with different authorisation number for each package
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